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NCT03165994 · ClinicalTrials.gov registry record · Phase 2
APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers
A Phase 2 study, sponsored by Apexigen America.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT03165994: Completed Phase 2 study, sponsored by Apexigen America.
NCT03165994 is a Phase 2 study that has completed, run by Apexigen America. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03165994, a Phase 2 study, has completed, sponsored by Apexigen America.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
This pilot phase II trial studies the therapeutic effects and side effects of CD40 agonistic monoclonal antibody APX005M when combined with chemotherapy and radiation therapy, and to see how well they work to reduce or remove esophageal or gastroesophageal (GE) cancers when given before surgery in treating patients with esophageal cancer or GE cancer than can be removed by surgery. APX005M is intended to stimulate the body's own immune system so that the immune cells can more effectively invade and destroy the tumor, adding to the benefits of the chemotherapy and radiation therapy. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving APX005M, chemotherapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Primary Outcome
The pCR was defined as post-neoadjuvant pathologic tumour, node, metastasis (ypTNM) (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. * T0: No evidence of primary tumor. * N0: Cancer has not spread to nearby lymph nodes. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- RADIATION Radiation Therapy
- DRUG APX005M
- PROCEDURE Surgical resection of tumor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2017-10-06 |
| Est. Completion | 2023-02-21 |
| Phase | Phase 2 |
What the finished NCT03165994 record still lists
NCT03165994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT03165994 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03165994 about?
NCT03165994 is a clinical study titled "APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers". This pilot phase II trial studies the therapeutic effects and side effects of CD40 agonistic monoclonal antibody APX005M when combined with chemotherapy and radiation therapy, and to see how well they work to reduce or remove esophageal or gastroesophageal (GE) cancers when given before surgery in t...
What is the current status of trial NCT03165994?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2017-10-06. Estimated completion is 2023-02-21.
What interventions are being tested in trial NCT03165994?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Radiation Therapy (RADIATION), APX005M (DRUG), Surgical resection of tumor (PROCEDURE).
Who is sponsoring clinical trial NCT03165994?
This trial is sponsored by Apexigen America, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03165994's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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